Apparatus for electrotherapy of the pubococcygeus

ABSTRACT

Apparatus for electrotherapy of the pubococcygeus muscle group of a female. The apparatus includes an electrode member contoured for insertion into the vagina. Spaced electrodes on the member are supplied with a carrier signal comprising shaped, bipolar pulses in the frequency range of from 20 Hz. to 8 kHz., the signal being carrier modulated at a rate of between 0.2 Hz. and 10 Hz. The bipolar pulses exercise striated muscle, while the low-frequency modulation contracts smooth muscle and prevents continuous tetany. A condom-type vaginometer permits measurement of vaginal volume and of vaginal pressure resulting from contraction of pubococcygeus muscles.

llnited States Patent De Langis [151 smmm 1 Feh.%,1972

[54] APPARATUS FOR ELECTROTHERAPY OF THE IPUBOCOCCYGEUS 21 Appl. No.:762

[52] U.S.Cl. ..l28/422, 128/2 S, 128/408 3,056,409 10/1962 Edwards..l28/422 Primary Examiner-Hugh R. Chamblee Attorney-Lyon & Lyon [5 7]ABSTRACT Apparatus for electrotherapy of the pubococcygeus muscle groupof a female. The apparatus includes an electrode member contoured forinsertion into the vagina. Spaced electrodes on the member are suppliedwith a carrier signal comprising shaped, bipolar pulses in the frequencyrange of from [51] int. Cl. ..A61n 01/06 20 to 8 KHZ, the Signal beingcarrier modulated at a r 58 Field of Search ..12s/2, 24.1,24.4, 407,408,of between and 10 The bipolar Pulses exercise 123/422 striated muscle,while the low-frequency modulation contracts smooth muscle and preventscontinuous tetany. A condom- 56] Reiereuces Cited type vaginometerpermits measurement of vaginal volume and of vaginal pressure resultingfrom contraction of pubococ- UNITED STATES PATENTS yg s mus le 3,403,68410/1968 Stiebel et a1. 128/407 4 Claims, 4 Drawing Figures POWER 217iii/f AMP 27 7'0 24 Z ELECT/Q0055 [0W I fiesagfgf 25 5/ flR06E'550/Q 28.92

22 MIA/VAL 2p AMPL I7'UOE CUII/TROL ER 29 cgfr t in rs 3/ CONSTANTCURRENT 0575670/2 PATENTED rsa 81972 EHEET W W 2 INVENTOR.

APPARATUS FOR ELECTROTIIERAPY OF THE PUBOCOCCYGEUS BACKGROUND OF THEINVENTION Primary muscular support for the female urogenital area isprovided by two muscle groups, the iliococcygeus and the pubococcygeus.If the pubococcygeus muscles are atonic or functioning inadequately, anumber of urogenital anomalies such as urinary stress incontinence anduterine prolapse may result. Moreover, poor functioning of thepubococcygeus muscles is a significant cause of female frigidity orsexual inadequacy.

Proper adjustment to sexual relations by married persons is asignificant element of happiness in marriage. Unsatisfactory adjustmentcan, and frequently does lead to unhappiness, to adverse affects onpersonality, and in many cases, to divorce. Therefore, it is importantthat married persons learn to perform their respective sexual roles aswell as possible, and that physicians have the means available to assistthem in doing so. To this end, awareness of the role played by thepubococcygeus muscles in female frigidity is of considerable importance.

In typical cases of apparent female frigidity, the strength of thepubococcygeus has been tested and the muscles found to be functioning atless than about percent of their optimum. In the past, gynecologistshave treated this problem by perscribing a series of exercises to beperformed by the female to tone up the pubococcygeus muscles. Theseexercises included voluntary contraction of the muscles in the midpelvicarea, and particularly of the muscles surrounding the middle onethird ofthe vagina. The result of such exercise was a very marked improvement insexual appreciation and response of the female. Often patients reportedthat they were feeling more sexually, and many indicated that they wereexperiencing vaginal orgasms for the first time in their lives.

Similar marked improvement in other urogenital anomalies have beenreported as a result of exercise of the pubococcygeus muscle. Forexample, women who experience urinary incontinence found that after aprogram of exercise of the pubococcygeus muscle they were able tocontrol bladder release to a degree not previously possible.

Electrotherapy has been used extensively in the past to exercise musclesof various parts of the body in cases where natural muscle function hasbeen lost or diminished. In such cases, the production of painless,graduated muscular exercise by electric stimulation reproduces thephysical and chemical phenomenon connected with normal muscular work.But despite the widespread use of electrotherapy for other parts of thebody, there have been virtually no reports of the application of suchtherapy to the female urogenital area.

SUMMARY OFTI-IE INVENTION muscles. Use of the inventive apparatusresults in significant improvement in the tone, strength and functioningof the pub'ococcygeus muscles. Benefits of such use includingsignificant reduction in female frigidity, relief from urinaryincontinence difiiculties and improvement of other urogenital anomalies.

The present electrotherapy apparatus includes electrical circuitry whichprovides a carrier signal comprising shaped bipolar pulses and having acarrier frequency in the range of from 20 Hz. to8 kHz., the signal beingcarrier modulated at a rate of between 0.2 Hz. and 10 Hz. The bipolarpulses exercise striated muscles, and are shaped so that a relativelylow-current initially is applied to the muscle, with a higher currentbeing applied once the muscle has contracted. The lowfrequency pulsemodulation exercises smooth muscle and prevents continuous tetany.

To measure the condition and performance of the pubococcygeus muscle,there is also disclosed a novel condom-type vaginometer which permitsmeasurement of the vaginal volume and of the pressure resulting fromcontraction of pubococcygeus muscles. The vaginometer comprises agenerally cylindrical condom holder having a shank region over which theopen end of a condom is stretched. An O-ring and an annular covermaintain the condom on the holder.

In use, the condom portion of the vaginometer is inserted in the vaginaand filled with water via an axial opening through the condom holder.The vaginal volume may be measured by determining the amount of waterrequired to fill the condom. By connecting a manometer to thevaginometer, the pressure resulting from contraction of pubococcygeusmuscles may be measured directly.

Thus, it is an object of the present invention to provide apparatus forelectrotherapy of the female pubococcygeus muscles.

Another object of the present invention is to provide an electrotherapyapparatus including an electrode member contoured for insertion into thevagina, and means for supplying a programmed electrical signal to theelectrode member for exercise of muscles in the pelvic region.

It is another object of the present invention to provide anelectrotherapy apparatus including circuitry to supply a carrier signalcomprising shaped bipolar pulses of a relatively high frequency, thecarrier signal being modulated at a relatively low frequency.

Yet another object of the present invention is to provide an apparatusfor electrotherapy of the pubococcygeus muscle group and including meansfor exercising both striated and smooth muscle and for preventingcontinuous tetany.

Still another object of the present invention is to provide an apparatusfor the electrotherapy of pubococcygeus muscles including means forapplying a relatively low current to the muscles before they havecontracted and a relatively larger current thereafter.

A further object of the present invention is to provide a novelvaginometer.

It is a further object of the present invention to provide a vaginometerof the condom-type, useful for measuring vaginal volume and vaginalpressure resulting from contraction of pubococcygeus muscles.

BRIEF DESCRIPTION OF THE DRAWINGS Still other objects, features andattendant advantages of the present invention will become apparent tothose skilled in the art from a description of the preferred embodimentsconstructed in accordance herewith, taken in conjunction with theaccompanying drawings, wherein like numerals designate like parts in theseveral figures, and wherein:

FIG. 1 is a perspective view of an electrode member contoured forinsertion into the vagina, and useful as part of the inventive apparatusfor electrotherapy of the pubococcygeus muscle group;

FIG. 2 is an electrical block diagram showing typical circuitry usefulfor providing a programmed electrical signal to the electrode member ofFIG. 1;

FIG. 2a graphically illustrates a typical waveform produced by thecircuitry of FIG. 2; and

FIG. 3 is a perspective view of a novel condom-type vaginometer usefulfor measuring vaginal volume and vaginal pressure resulting fromcontraction of pubococcygeus muscles.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to tlne drawings,and particularly to FIGS. 1 and 2 thereof, there is shown a preferredembodiment of the inventive apparatus for electrotherapy of thepubococcygeus muscle group. In general, the apparatus comprises agenerally tubular electrode member (FIG. 1) which is contoured forinsertion into the vagina. Member 10 includes a pair of Iongitudinallyspaced, circumferential electrodes 11 and 12 to which is supplied aprogrammed electrical signal from the circuitry 13 of FIG. 2.

Referring in greater detail to FIG. 1, electrode member 10 includes aclosed end 14 of generally hemispherical shape, and an open end 15 whichis outwardly flared. Member 10 preferably is constructed of plastic orother smooth, electrically nonconductive material. Electrodes l1 and 12are flush with the exterior surface of member 10, and are positionedwith electrode 11 adjacent end 14 and electrode 12 spaced approximatelyone-third of the way back toward end 15. The interior 16 of tubularmember 10 houses a pair of electrode wires 17 and 18 which arerespectively connected to electrodes l1 and 12 interiorly thereof.Electrode wires 17 and 18 extend out through flared end 16, and areconnected to the electrical circuitry of FIG. 2, as described below.

For effective electrotherapy of the pubococcygeus muscle group, it isdesirable to supply to electrodes 11 and 12 a signal having bothhigh-frequency and low-frequency components. Illustrative circuitry forproviding such a signal is shown in FIG. 2. Referring thereto, circuitry13 includes an oscillator 20 having a frequency in the range of from 20Hz. to 8 kHz., and preferably in the range of from 150 Hz. to 1 kHz.Bipolar output pulses from oscillator 20 are shaped by a high-frequem cysignal processor 21, typically a passive filter network, which providesa gradual rise time to each pulse. As will be described below, thisshaping is desirable to provide initially low current to the striatedmuscles of the pubococcygeus, followed by a relatively higher currentonce these muscles have contracted. The output of oscillator 20 also isshaped by a lowfrequency signal processor 22 which in effect introducesa low-frequency carrier modulation in the frequency range of from 0.2 to10 Hz., and preferably in the range of from 0.5 to 1 Hz.

The shaped and modulated signals from processors 21 and 22 are combinedin a conventional summing amplifier 23 to provide on a line 24 a carriersignal comprising shaped bipolar pulses and having a frequency in therange of from 20 Hz. to 8 kHz., the carrier signal being modulated at alow frequency in the range of from 0.2 to 10 Hz. This signal on line 24is amplified by an automatic gain control (AGC) amplifier 25 and by apower amplifier 26, and the amplified signal provided via a terminal 27to one of electrodes 11 and 12 of member 10. The other of electrodes 11and 12 is connected to a temninal 28 associated with a constant currentdetector 29.

The average current flowing between electrodes 11 and 12 is sensed byconstant current detector 29 which provides along a line 30 a signalindicative of the sensed current level. The signal on line 30 issupplied to an automatic gain control (AGC) driver 31 which in turncontrols the gain of AGC amplifier 25 in a manner so as to maintain theaverage current between electrodes 11 and 12 at a generally constantlevel. A manual amplitude control 32 associated with AGC driver 31permits operator selection of the average current level provided toelectrode member 10. Preferably, average current levels below about 250milliamperes may be employed. A power supply 33 provides DC power tooperate oscillator 20 and the other components of circuitry 13.

The circuitry of FIG. 2 is illustrative only, and other electronics maybe used to produce the programmed electrical signal to electrode member10. However, the excitation signal provided to electrodes 11 and 12should include both highfrequency and low-frequency components. Thereason for this is that the pelvic area muscle group includes bothstriated and smooth muscle, both of which must be considered in anyprocess of pelvic rehabilitation. Experiments have proved thateffective, painless vaginal muscle stimulation requires bipolar pulsesof relatively high frequency (20 Hz. to 8 kHz.) to contractstriatedmuscle and relatively low frequency (0.2 to l0 Hz.) bipolarpulses to contract the smooth muscle. The optimum frequencies for thesebipolar pulses vary somewhat from patient to patient, but generally arein the range of from Hz. to l kHz. for the high-frequency component andfrom 0.5 to l Hz. for the low-frequency component. As mentionedhereinabove, the low-frequency component may be introduced by carriermodulating a high-frequency signal comprising bipolar pulses.

The wave shape of the bipolar pulses comprising the relativelyhigh-frequency component of the excitation signal to electrode member 10is not critical. In fact, both sine wave and square wave signals havebeen found to work effectively. However, for optimum exercise ofstriated muscle, it is desirable that the pulses be shaped to provide aninitially low current, followed by a considerably higher current as themuscle starts to contract. Similarly, the shape of the low-frequencycarrier modulation is not critical. However, a relatively slow rise timeagain is desirable to provide an initially low current to the smoothmuscles, followed by a higher current when these muscles begin tocontract. FIG. 2a shows a typical signal produces by the circuit of FIG.2; the shape of the lowfrequency modulation is clearly evident. However,signals having waveshapes other than that illustrated in FIG. 2a may beused effectively with the inventive apparatus.

The low-frequency component of the excitation signal, in addition tocausing contraction of smooth muscle, also functions to avoid continuoustetany of the striated muscles. This is desirable, since if the striatedmuscle were continuously contracted by the high-frequency component, themuscle would tend to accommodate or relax, and little or no effectiveexercise of the striated muscle would result despite continuedapplication of the bipolar pulses. By interrupting or modulating thehigh frequency carrier at a low-frequency rate, such continuous tetanyis avoided, and the striated muscle has no chance to acconunodate orrelax.

The shaping of the highand low-frequency signal compornents also servesthe function of eliminating very highfrequency components (in excess ofseveral thousand Hz.) which develop heat within the tissue and/orstimulate the pain receptors. This insures that the electrotherapy willbe painless to the patient. Moreover, the low-frequency component allowsuse of the present apparatus on both innervated and denervated muscles.

In operation, electrode member 10 is inserted into the vagina of thepatient, possibly using a lubricant such as water. Electrode wires 17and 18 are connected to terminals 27 and 28 of circuitry 13 (FIG. 2),and the manual amplitude control 32 is given to the patient. The patientincreases the amplitude of the excitation signal from circuitry 13 to apoint where pubococcygeus muscle contractions occur. Because ofaccommodation, the patient typically will increase the amplitude of theexcitation signal from time to time during the treatment. Optimum muscleexercise was found to occur when electrodes 11 and 12 were positionedover the motor points of the pubococcygeus.

Significant improvement in the tone, strength and functioning of thepubococcygeus muscle group was found to result from regular use of theinventive electrotherapy apparatus. To facilitate actual quantitativemeasurement of this improvement, the Vaginometer of FIG. 3 wasdeveloped. This device permits measurement of the vaginal volume andalso of the vaginal pressure resulting when the pubococcygeus musclesare contracted.

Referring to FIG. 3, vaginomenter 40 comprises a generally cylindricalcondom holder 41 having a vaginal shank region 42 of relatively smalldiameter and a flared body region 43 of relatively larger diameter. Anaxial opening 44 extends through condom holder 41. Attached rearwardlyof condom holder 41 is a disc-shaped back plater 45 having a centralopening 46. Vaginometer 40 also includes an Oring 47 and an annularcover 48 of plastic, hard rubber or the like. The diameter of centralopening 49 in cover 48 is slightly larger than the outer diameter ofshank region 42 of condom holder 41.

weeks is indicated for each patient, as well as the total number oftreatments. Typically, individual treatments were of about one-half hourin duration. The vaginal volume and vaginal pressure resulting fromcontraction of pubococcygeus muscles As illustrated in FIG. 3, the band50 of a condom 51 is 5 prior to the treatment period isindicated, andthe correspondstretched over shank region 42 of holder 41, and thecondom ing vaginal volume and pressure values measured at the end ofthreaded thro gh O-rmg 47 and ann lar cover 48 The O-rmg the treatmentperiod also are listed. Note that as a control, 47 and cover 48 arePosmoned about Shank 8 42 to Table 1 includes data for two patients(Case Nos. 6 and 7) secure the condom open end 52 to holder 41. Cover 48h i d no t t nt,

TABLE I Pre-treatment Post-treatment Period of Patient treatment, Numberof Volume, Vaginal Volumev Vaginal case no. (weeks) treatments (1111.)pressure (mL) prcssult 16 22 130 5 125 11s 12 35 150 0 140 110 s 150 *is150 140 4 11 280 3 2x5 17 3. 5 10 150 *3 1511 *50 4 0 160 4 11m 5 4 0150 *5 155 *5 *Cornbined vaginal and abdominal pressure.

prevents condom 51 from forming an aneurism outside the vagina whichwould give erroneous pressure and volume readings. Further, the vaginalorifice shank 42 is provided to assist in holding the vaginometer in thevagina, and to eliminate false pressure readings which might otherwiseresult should the patient contract the vaginal orifice.

When vaginometer 40 is assembled as described, condom 51 may be filledwith water or other fluid supplied underpressure from a syringe (notshown) via an inlet tube 530 (FIG. 3), a valve 54 and a tube 55 whichcommunicate with the interior of condom 51 via axial openings 44 and 46.For pressure measurement, a manometer (not shown) is connected for fluidcommunication with the interior of condom 51 via a line 56, valve 54 andtube 55. Valve 54 permits selection of whether vaginometer 40 isconnected to inlet tube 53, so as to permit filling of condom 51, or toline 56, so as to facilitate manometer measurement of vaginal pressure.

In operation, the condom portion 51 of vaginometer 40 is inserted intothe vagina with shank portion 42 of condom holder 41 extending into thevaginal orifice. With valve 54 positioned to provide fluid communicationbetween tubes 53 and 55, condom 51 may be filled with warm water from asyringe (not shown). Typically, the condom is unfused with water until atare pressure of millimeters of mercury (mm. Hg.) is observed. Thepatient then is asked to contract rapidly the vaginal and abdominalmuscles. When this exercise is stopped, the condom water pressure againis checked. If the vaginometer pressure has changed, more water isinfused and the exercise repeated until a constant pressure is obtained.This insures complete vaginal filling. The amount of water required 1 tofill condom 5 1 then is indicative of the vaginal volume.

To determine vaginal pressure resulting from contraction ofpubococcygeus muscles, vaginometer is inserted in the vagina and filledwith fluid as described above. The patient is asked to contract thevaginal muscles only, with the lungs empty. During the measurement, theabdomen may be palpated to ensure that the abdominal muscles are notcontracting. To obtain the vaginal pressure reading, valve 54 is turnedto provide fluid communication between the manometer line 56 and theinterior of condom 51, via tube 55. Typically, the patient is asked tomaintain this pubococcygeus contraction for about 10 seconds while amanometer pressure reading is taken.

The significant improvement is muscle tone, strength and functioning ofthe pubococcygeus resulting from treatment with the inventiveelectrotherapy apparatus is illustrated by the statistics in thefollowing Table ll, derived from actual paticnt case histories. In thistable, the period of treatment in As is evident from Table l, in eachcase, a very significant increase in vaginal pressure resulted at theend of the treatment period. This increase in pressure is indicative ofthe improved pubococcygeus muscle tone, strength and functioningresulting from use of the inventive apparatus. Typically, patients noteda significant increase in sexual interest and activity after treatmentwith the inventive electrotherapy apparatus. Moreover, in cases ofurinary incontinence and other female urogenital anomalies, definiteimprovements also resulted when the pubococcygeus muscles were exercisedand toned up by use of the apparatus described herein.

Although reference is made herein for use of the apparatus in connectionwith the vagina of a female, it is to be understood that the apparatusmay also be used for the male or female as a rectal probe or electrode.

While the invention has been described with respect to several physicalembodiments constructed in accordance therewith, it will be apparent tothose skilled in the art that various modifications and improvements maybe made without departing from the scope and spirit of the invention.

I claim:

1. Apparatus for electrotherapy including, a pair of spaced electrodes;means developing a carrier wave which is substantially a sine wavehaving a frequency within the range of Hz. to 1 kHz., means amplitudemodulating said carrier wave with a modulating signal having a frequencysubstantially less than said carrier frequency and producing a series ofrecurrent bipolar pulses with each of said pulses having a durationestablished by said modulating signal and consisting of varia tions inits amplitude at said carrier wave frequency from a maximum positivevalue, to a zero value to a maximum negative value, to a zero value to amaximum positive value, and so forth; and means connected to saidamplitude modulating means and continuously modifying said maximumpositive values and said maximum minimum values such that they becomeprogressively larger at a slower rate during initial development of eachof said pulses than during subsequent development such that each of saidbipolar pulses is defined by a slowly rising portion followed by aportion of substantially constant amplitude; and means applying saidbipolar pulses to said electrodes.

2. Apparatus as set forth in claim 1 in which modulating frequency is inthe range of 150 Hz. to 1 kHz.

3. Apparatus as set forth i claim 1 in which said modulating frequencyis within the range of 0.5 Hz. to 1 kHz.

4. Apparatus as defined in claim 1 including means for limiting thecurrent flow to said electrodes to a value which does not exceed 250milliamperes.

* w n t n

1. Apparatus for electrotherapy including, a pair of spaced electrodes;means developing a carrier wave which is substantially a sine wavehaving a frequency within the range of 150 Hz. to 1 kHz., meansamplitude modulating said carrier wave with a modulating signal having afrequency substantially less than said carrier frequency and producing aseries of recurrent bipolar pulses with each of said pulses having aduration established by said modulating signal and consisting ofvariations in its amplitude at said carrier wave frequency from amaximum positive value, to a zero value to a maximum negative value, toa zero value to a maximum positive value, and so forth; and meansconnected to said amplitude modulating means and continuously modifyingsaid maximum positive values and said maximum minimum values such thatthey become progressively larger at a slower rate during initialdevelopment of each of said pulses than during subsequent developmentsuch that each of said bipolar pulses is defined by a slowly risingportion followed by a portion of substantially constant amplitude; andmeans applying said bipolar pulses to said electrodes.
 2. Apparatus asset forth in claim 1 in which modulating frequency is in the range of150 Hz. to 1 kHz.
 3. Apparatus as set forth in claim 1 in which saidmodulating frequency is within the range of 0.5 Hz. to 1 kHz. 4.Apparatus as defined in claim 1 including means for limiting the currentflow to said electrodes to a value which does not exceed 250milliamperes.